FDA responses to FOIA requests on COVID vaccines – not a conspiracy

FDA FOIA

This article about FDA responses to Freedom of Information Act (FOIA) requests by anti-vaccine activists was written by Dorit Rubinstein Reiss, Professor of Law at the University of California Hastings College of the Law (San Francisco, CA), who is a frequent contributor to this and many other blogs, providing in-depth, and intellectually stimulating, articles about vaccines, medical issues, social policy, and the law.

Professor Reiss writes extensively in law journals about the social and legal policies of vaccination. Additionally, Reiss is also a member of the Parent Advisory Board of Voices for Vaccines, a parent-led organization that supports and advocates for on-time vaccination and the reduction of vaccine-preventable disease. She is also a member of the Vaccines Working Group on Ethics and Policy.

In contrast to anti-vaccine claims (and the headline that echoed them), the FDA responses to a broad Freedom of Information Act (FOIA) requests are not evidence of a conspiracy or some kind of unusual problem (though it may reflect some of the general issues with our FOIA system).

In a recent set of posts by anti-vaccine activists, they criticized FDA for, allegedly, wanting 55 years to process a FOIA request for vaccine data. Unfortunately, some media sources repeated the claim uncritically. 

The reality, unsurprisingly, is different. A group that includes several anti-vaccine activists and people who have had anti-vaccine support in the past submitted a very broad request for documents related to the Pfizer-BioNTech vaccine trial.

These documents need to be redacted before being released, to protect interests like patient privacy and trade secrets. The parties are wrangling about the rate at which FDA should process those documents, and the anti-vaccine talking point is basically a misrepresentation of the FDA’s position about the schedule. Here is the report of both parties’ positions to the courts.

FDA explained that this is a very large request, it is one of several hundred they are dealing with, and their FOIA office is small. It wants to provide it at a rate of 500 pages a month, a rate that, from cases cited by FDA, has been repeatedly accepted by courts as reasonable (reflecting standard practice) and has already started providing some of the data. The group is demanding all the information in the next four months. The court will have to decide what is the appropriate rate of release. 

To emphasize — at no point did FDA ask the plaintiffs to wait 55 years for documents. The FDA offered to start releasing documents immediately, and work at a rate of 500 pages a month after December 1, releasing 500 pages to the plaintiffs each month – in order of priorities set by the plaintiffs.

This post will examine numerous issues surrounding FOIA requests to the FDA, and whether the responses by the FDA are reasonable or not.

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Supreme Court and Religious Freedom from vaccine mandates – why we should worry

supreme court vaccine mandates

This article about the Supreme Court and how it may use religious freedom against vaccine mandates was written by Dorit Rubinstein Reiss, Professor of Law at the University of California Hastings College of the Law (San Francisco, CA), who is a frequent contributor to this and many other blogs, providing in-depth, and intellectually stimulating, articles about vaccines, medical issues, social policy, and the law. Professor Reiss writes extensively in law journals about the social and legal policies of vaccination. Additionally, Reiss is also a member of the Parent Advisory Board of Voices for Vaccines, a parent-led organization that supports and advocates for on-time vaccination and the reduction of vaccine-preventable disease. She is also a member of the Vaccines Working Group on Ethics and Policy.

On 29 October 2021, the Supreme Court rejected a request to stay – put on hold – Maine’s vaccine mandates for healthcare workers, which did not include a religious exemption. Many people in the immunization community are excited and happy about this decision.

Without wanting to be a downer, I want to explain why this decision – though certainly better than the alternative, staying the mandate – should cause us concern. Basically, three justices on the Court signed onto an opinion that essentially says that public health writ large is not a compelling state interest (in the middle of a deadly pandemic), that thinks that the right comparison is one religious exemption to one medical exemption (rather than consider aggregate effects) and that if other states are less protective of their citizens’ health, a state can’t limit religion to protect its citizens better.

What was not in the decision is any concern about the effects of COVID-19, a disease that is still killing over 1,000 Americans a day. That is highly problematic. But more concerning is the fact that two other justices were not willing to stay the mandate via emergency proceedings, but saying no more, implying that they are open to considering requiring a religious exemption (though they are certainly not saying they would – and these justices probably could use more information on why requiring a religious exemption from vaccines mandates is problematic). 

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Catie Clobes v NBC – problematic anti-vaccine lawsuit against a journalist, Part 2

clobes nbc

This article, part 2 of the Catie Clobes v NBC anti-vaccine lawsuit, was written by Dorit Rubinstein Reiss, Professor of Law at the University of California Hastings College of the Law (San Francisco, CA), who is a frequent contributor to this and many other blogs, providing in-depth, and intellectually stimulating, articles about vaccines, medical issues, social policy, and the law.

Professor Reiss writes extensively in law journals about the social and legal policies of vaccination. Additionally, Reiss is also a member of the Parent Advisory Board of Voices for Vaccines, a parent-led organization that supports and advocates for on-time vaccination and the reduction of vaccine-preventable disease. She is also a member of the Vaccines Working Group on Ethics and Policy.

In part 1, I explained the elements of defamation and why Ms. Clobes will likely be a limited-purpose public figure for her lawsuit against NBC. This lawsuit would require her to prove actual malice, which she has neither alleged nor is likely to be able to show.

In this post, I will explain why Ms. Clobes is also unlikely to be able to prove the claims against NBC in the article are false. As a reminder, “Only false statements of fact can be defamatory. Arguments, characterizations, insults, and aspersions can’t be unless they are premised on explicit or implied false statements of fact.” The claims that large parts of the article being opinion and not fact is essentially negating their case. Any parts of the article that are opinions are not defamation. 

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Catie Clobes v NBC – problematic anti-vaccine lawsuit against a journalist, Part 1

scrabble tiles

This article about the Catie Clobes v NBC lawsuit was written by Dorit Rubinstein Reiss, Professor of Law at the University of California Hastings College of the Law (San Francisco, CA), who is a frequent contributor to this and many other blogs, providing in-depth, and intellectually stimulating, articles about vaccines, medical issues, social policy, and the law.

Professor Reiss writes extensively in law journals about the social and legal policies of vaccination. Additionally, Reiss is also a member of the Parent Advisory Board of Voices for Vaccines, a parent-led organization that supports and advocates for on-time vaccination and the reduction of vaccine-preventable disease. She is also a member of the Vaccines Working Group on Ethics and Policy.

On September 24, 2021, anti-vaccine activist Catelin (Catie) Clobes filed a lawsuit in federal district court in Minnesota against NBC and two of its journalists, Brandy Zadrozny and Aliza Nadi, alleging defamation, emotional distress [sic], and “reasonable care” [sic].

The review of Catie Clobes v NBC is quite long, so this article will be published in two parts, with the second one being available tomorrow.

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Vaccine informed consent – is it in tension with school mandates?

vaccine informed consent

This article about vaccine informed consent was written by Dorit Rubinstein Reiss, Professor of Law at the University of California Hastings College of the Law (San Francisco, CA), who is a frequent contributor to this and many other blogs, providing in-depth, and intellectually stimulating, articles about vaccines, medical issues, social policy, and the law.

Professor Reiss writes extensively in law journals about the social and legal policies of vaccination. Additionally, Reiss is also a member of the Parent Advisory Board of Voices for Vaccines, a parent-led organization that supports and advocates for on-time vaccination and the reduction of vaccine-preventable disease. She is also a member of the Vaccines Working Group on Ethics and Policy.

Several people have asked me whether having school mandates is in tension with the idea of vaccine informed consent. The answer is no. While school mandates have some effect on parental autonomy, the doctrine of informed consent should not be conflated with autonomy.

For a somewhat different reason, imposing sanctions on those who do not vaccinate is also not a violation of informed consent.

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NVICP compensation and autoimmune syndromes – vaccine court review

brown wooden gavel on brown wooden table

This article about NVICP compensation and autoimmune syndromes was written by Dorit Rubinstein Reiss, Professor of Law at the University of California Hastings College of the Law (San Francisco, CA), who is a frequent contributor to this and many other blogs, providing in-depth, and intellectually stimulating, articles about vaccines, medical issues, social policy, and the law.

Professor Reiss writes extensively in law journals about the social and legal policies of vaccination. Additionally, Reiss is also a member of the Parent Advisory Board of Voices for Vaccines, a parent-led organization that supports and advocates for on-time vaccination and the reduction of vaccine-preventable disease. She is also a member of the Vaccines Working Group on Ethics and Policy.

This post examines the treatment by the National Vaccine Injury Compensation Program (NVICP) of the second of two claims (see first one here) heard from those claiming vaccines cause more injuries than acknowledged in recent days. This article will focus on NVICP compensation and autoimmune syndromes.

The Special Master’s decisions – as many decisions in NVICP are – are long, complex, and examine the evidence closely and in detail. They address factual debates, expert disagreements specific to the case, and expert disagreements on the science.

This post won’t cover them – that’s not my goal. All I will address are the Special Master’s conclusion about two hypotheses raised by those who believe vaccines injured their child (and also promoted by anti-vaccine organizations).

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A review of how the vaccine court deals with SIRVA claims

SIRVA vaccine court

This article about the vaccine court and SIRVA claims was written by Dorit Rubinstein Reiss, Professor of Law at the University of California Hastings College of the Law (San Francisco, CA), who is a frequent contributor to this and many other blogs, providing in-depth, and intellectually stimulating, articles about vaccines, medical issues, social policy, and the law.

Professor Reiss writes extensively in law journals about the social and legal policies of vaccination. Additionally, Reiss is also a member of the Parent Advisory Board of Voices for Vaccines, a parent-led organization that supports and advocates for on-time vaccination and the reduction of vaccine-preventable disease. She is also a member of the Vaccines Working Group on Ethics and Policy.

In this article, we are going to take a look at how “shoulder injury related to vaccine administration” (SIRVA) relates to the National Vaccine Injury Compensation Program (NVICP), often called the Vaccine Court, claims. In 1986, the United States Congress passed the National Childhood Vaccine Injury Act, which among other things created the  NVICP. The act’s main goal was to protect vaccine manufacturers from vaccine injury claims and liability–but not for the reasons you might think. 

Congress was rightly concerned that the costs for these legal actions were going to drive most, if not all, manufacturers from the USA market. That would have been a horrific problem for the country, with no ability to protect children from deadly and dangerous diseases.

The NVICP provides a no-fault program to resolve vaccine injury claims – “quickly, easily, with certainty and generosity.” The program was (and continues to be) funded by a tax on all vaccines sold in the country. Moreover, using a system of expert administrative “judges” (called Special Masters), a petitioner seeking to establish causation-in-fact must show, by a preponderance of the evidence, that but for the vaccination, they would not have been injured, and that the vaccination was a substantial factor in bringing about their injury.

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How does the vaccine court deal with SIRVA claims? A review

SIRVA vaccine court

This article about the vaccine court and SIRVA claims was written by Dorit Rubinstein Reiss, Professor of Law at the University of California Hastings College of the Law (San Francisco, CA), who is a frequent contributor to this and many other blogs, providing in-depth, and intellectually stimulating, articles about vaccines, medical issues, social policy, and the law.

Professor Reiss writes extensively in law journals about the social and legal policies of vaccination. Additionally, Reiss is also a member of the Parent Advisory Board of Voices for Vaccines, a parent-led organization that supports and advocates for on-time vaccination and the reduction of vaccine-preventable disease. She is also a member of the Vaccines Working Group on Ethics and Policy.

In this article, we are going to take a look at how “shoulder injury related to vaccine administration” (SIRVA) relates to the National Vaccine Injury Compensation Program (NVICP) claims. In 1986, the United States Congress passed the National Childhood Vaccine Injury Act, which among other things created the  NVICP, sometimes called the Vaccine Court. The act’s main goal was to protect vaccine manufacturers from vaccine injury claims and liability–but not for the reasons you might think. 

Congress was rightly concerned that the costs for these legal actions were going to drive most, if not all, manufacturers from the USA market. That would have been a horrific problem for the country, with no ability to protect children from deadly and dangerous diseases.

The NVICP provides a no-fault program to resolve vaccine injury claims – “quickly, easily, with certainty and generosity.” The program was (and continues to be) funded by a tax on all vaccines sold in the country. Moreover, using a system of expert administrative “judges” (called Special Masters), a petitioner seeking to establish causation-in-fact must show, by a preponderance of the evidence, that but for the vaccination, they would not have been injured, and that the vaccination was a substantial factor in bringing about their injury.

Continue reading “How does the vaccine court deal with SIRVA claims? A review”

Did Japan ban Gardasil? No, but the anti-vaccine crowd loves the trope

Japan Banned Gardasil

One of the most popular zombie memes and tropes of the anti-vaccine movement is that Japan banned Gardasil, the HPV vaccine. And like most of those zombie memes and tropes, the facts are a lot different than the anti-vaccine claims. Shocking, I know.

Although I don’t quite understand the reasoning, the anti-vaccine world absolutely hates Gardasil, possibly more than any other vaccine other than COVID-19 vaccines (of course). These zealots maintain that the HPV vaccines cause all kinds of harm to teens and young adults. Yet, there are literally mountains of data derived from numerous huge epidemiological studies that the Gardasil cancer-preventing vaccine is one of the safest vaccines on the market.

So if you really want to prevent cancer, one of the best ways available to you is getting the HPV vaccine. The idea is so simple, yet is clouded by the myths about HPV vaccines – one of the most popular, of course, is that Japan banned Gardasil. Let’s examine this fable with a critical and skeptical eye.

Spoiler alert – Japan did no such thing.

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COVID-19 vaccine liability – new information after FDA approval

small judge gavel placed on table near folders

This article about COVID-19 vaccine liability was written by Dorit Rubinstein Reiss, Professor of Law at the University of California Hastings College of the Law (San Francisco, CA), who is a frequent contributor to this and many other blogs, providing in-depth, and intellectually stimulating, articles about vaccines, medical issues, social policy, and the law.

Professor Reiss writes extensively in law journals about the social and legal policies of vaccination. Additionally, Reiss is also a member of the Parent Advisory Board of Voices for Vaccines, a parent-led organization that supports and advocates for on-time vaccination and the reduction of vaccine-preventable disease. She is also a member of the Vaccines Working Group on Ethics and Policy.

A number of questions have come up around COVID-19 vaccine liability. I previously addressed the general framework for liability. In this article, I will try to outline how individuals may be liable for potential harm from COVID-19 vaccines especially in light of the recent FDA approval of the Pfizer vaccine.

Also, this short post addresses a bit of misinformation that appears to have come up from anti-vaccine sources.

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